510(k) Report

510(k) · Cleared

Cleared

Volumax CT Imaging System

K982060510(k) TraditionalCleared Sep 2, 199883-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Elscint, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Sep 2, 1998 as substantially equivalent to K945512 (Elscint, Inc., 1995) and 3 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1993. 264 later devices descend from it.

Decided
Sep 2, 1998
Review
83 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K930090 (1993). 6 ancestors in all. 264 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestors2001: 1 descendant cleared2004: 7 descendants cleared2008: 7 descendants cleared2003: 3 descendants cleared2009: 4 descendants cleared2017: 12 descendants cleared2011: 4 descendants cleared2007: 3 descendants cleared2005: 3 descendants cleared2016: 5 descendants cleared2006: 3 descendants cleared2015: 3 descendants cleared2018: 14 descendants cleared2019: 9 descendants cleared2014: 9 descendants cleared2013: 6 descendants cleared2010: 2 descendants cleared2012: 6 descendants cleared2020: 22 descendants cleared2024: 19 descendants cleared2023: 20 descendants cleared2025: 35 descendants cleared2022: 22 descendants cleared2021: 19 descendants cleared2026: 26 descendants clearedK930090 · Helicat · Elscint, Inc. · 1993K961464 · Select/SP · Elscint, Inc. · 1996 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 11 descendants3 generations forward: 24 descendants4 generations forward: 43 descendants5 generations forward: 43 descendants6 generations forward: 29 descendants7 generations forward: 30 descendants8 generations forward: 26 descendants9 generations forward: 17 descendants10 generations forward: 13 descendants11 generations forward: 8 descendants12 generations forward: 10 descendants13 generations forward: 6 descendants14 generations forward: 2 descendants15 generations forward: 1 descendant K961464 · Select/SP · Elscint, Inc. · 1996 · recalledK930090 · Helicat · Elscint, Inc. · 19930+5+10+15
  1. Root · 2 generations backK930090 HelicatElscint, Inc. · 1993
  2. 1 generation backK961464 Select/SPElscint, Inc. · 1996 · Recalled
  3. This deviceK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
  4. Descendant · cites it directly · 263 of its ownK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
  5. Descendant · 2 generations on · 214 of its ownK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
  6. Descendant · 2 generations on · 147 of its ownK042293 Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
  7. Descendant · 3 generations on · 92 of its ownK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
  8. Descendant · 4 generations on · 91 of its ownK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled

Showing 5 of 264 descendants. See all descendants

Descendants cleared per year

2001: 12003: 32004: 72005: 32006: 32007: 32008: 72009: 42010: 22011: 42012: 62013: 62014: 92015: 32016: 52017: 122018: 142019: 92020: 222021: 192022: 222023: 202024: 192025: 352026: 26
2001high 35 (2025) · low 0 (2002)2026

Most influential descendants

Showing 5 of 264 · See all
  • K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · cites it directly263descendants
  • K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · 2 generations on214descendants
  • K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · 2 generations on147descendants
  • K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013 · 3 generations on92descendants
  • K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · 4 generations on91descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K930090HelicatElscint, Inc.1993—
−1K961464Select/SPElscint, Inc.19963
0 (this device)K982060Volumax CT Imaging SystemElscint, Inc.1998—
+1K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc.200161
+2K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc.2003131
+2K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc.20041
+3K130159Qlab Quantification Software Heart ModelPhilips Health Care2013—
+4K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.20131

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199510
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200330
200470
200530
200630
200730
200870
200940
201020
201140
201260
201360
201490
201530
201650
2017120
2018140
201990
2020220
2021190
2022220
2023200
2024190
2025350
2026260
FIG. 1 — Lineage of K982060, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JAK device

  1. #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K945512HRSW Option for CT Twin Flash
Summary page 1
…g. e Minimum scan time of 0.3 second. e Minimum reconstruction time of 0.5 second. 4. Predicate Devices ¢ CT-Twin flash submitted in “HRSW Option for CT-Twin Flash” K945512. ¢ SeleCT/SP, K961464 ¢ OmniPro which is a trade name of ProVision, K954678 Related devices: - XRT-7 Option for CT scanner, K…
Elscint, Inc.1995—
*K961464Select/SP
Summary page 1
…e of 0.3 second. e Minimum reconstruction time of 0.5 second. 4. Predicate Devices ¢ CT-Twin flash submitted in “HRSW Option for CT-Twin Flash” K945512. ¢ SeleCT/SP, K961464 ¢ OmniPro which is a trade name of ProVision, K954678 Related devices: - XRT-7 Option for CT scanner, K964583 _ Siemens Somato…
Elscint, Inc.19963
*K941546Somatom Project 059
Summary page 1
…K945512. ¢ SeleCT/SP, K961464 ¢ OmniPro which is a trade name of ProVision, K954678 Related devices: - XRT-7 Option for CT scanner, K964583 _ Siemens Somatom Plus 4, K941546, K964747 - Siemens Magnetom Project O16, K932271 510(k) Summary 5. Safety and Effectiveness Considerations The…
Siemens Corp.1994—
*K964747Somatom Plus 4 CT Scanner
Summary page 1
…¢ SeleCT/SP, K961464 ¢ OmniPro which is a trade name of ProVision, K954678 Related devices: - XRT-7 Option for CT scanner, K964583 _ Siemens Somatom Plus 4, K941546, K964747 - Siemens Magnetom Project O16, K932271 510(k) Summary 5. Safety and Effectiveness Considerations The safety o…
Siemens Medical Solutions USA, Inc.1997—

Also cleared against K945512: 3 other devices →

What descends from it? (264)

See all 264

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc.2001263

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K012009 (Marconi Medical Systems, Inc., 2001) has gone furthest, with 263 descendants of its own.
  • 3 other devices also cite its predicate K945512.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

What is it indicated for?

Whole body computerized tomography.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K945512

3 other devices cite the same predicate.

  • K974344CT ScopeElscint, Inc. · 1998
  • K970980Cardiac Scoring for CT ScannersElscint, Inc. · 1997
  • K964583XRT-7.0Elscint, Inc. · 1997

More from Elscint, Inc.

97 FDA decisions under this applicant name. See the company

  • K983313Advanced Automatic Detector Selection Option for GloryElscint, Inc. · 1998
  • K974344CT ScopeElscint, Inc. · 1998
  • K980306Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-EPElscint, Inc. · 1998
  • K974614Gyrex 2T Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1TG 100-6250-0102Elscint, Inc. · 1998
  • K9725922T Prestige (100-6321-0107)/Privilege (100-6326-0102)/Gyrex V-EP (100-6327-0101)Elscint, Inc. · 1997

Recent decisions in JAK

The JAK category page

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  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
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https://510kreport.com/device/K982060 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982060: Volumax CT Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982060

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026